Health product recall

ALOKA ARIETTA 850

Last updated

Summary

Product
ALOKA ARIETTA 850
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information

Affected products

Affected Products

Lot or serial number

Model or catalog number

ALOKA ARIETTA 850

S/N G3042822
S/N G3042825
S/N G3042826

ALOKA ARIETTA 850

Issue

Two issues with the diagnostic ultrasound system Arietta 850 (software version V1.0.0 - V4.1.3) Used in combination with a Fujifilm (formally Hitachi) Transducer: (1) the calculation result of eroa is displayed incorrectly when measuring lvot flow, lvot and MR flow. This error also appears in the user manual. (2) The calculation result for MVA (VTI) is displayed incorrectly when measuring MV.

Recall start date: 2021-10-26

Additional information

Details
Original published date: 2021-11-19
Alert / recall type
Health product recall
Category
Health product - Medical device - Obstetrics and gynaecology
Companies

FUJIFILM HEALTHCARE CORPORATION

2-1 SHINTOYOFUTA, KASHIWA-SHI

Chiba-Ken, Japan

277-0804

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63615